Aseptic Process Specialist

Fagron Sterile Services US (FSS); Wichita (KS); On-site; USD 95,000 - 120,000; Full time

Job summary

Fagron Sterile Services US (FSS) is seeking an Aseptic Process Specialist to organize and oversee the aseptic process simulation program at the 503B facility. You will coordinate design, execution, and implementation of media-fill protocols to qualify aseptic operations across multiple lines, reporting to Manufacturing Quality.

You will collaborate with Validation, Production, QA, and Aseptic Training teams to ensure scientific soundness, FDA 503B compliance, and continuous improvement of

Qualifications

• Bachelor's degree in Microbiology, Life Sciences, Engineering, or related discipline (advanced degree preferred).
• Minimum 5 years in sterile pharmaceutical manufacturing or 503B compounding.
• Understanding FDA 503B guidance, cGMP (21 CFR Parts 210/211), and Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing current Good Manufacturing Practice.
• Leadership and project management capabilities.
• Communication, problem-solving, and decision-making skills.
• Proficiency in electronic quality systems, deviation management, and protocol/repor authorship.
• Quality-driven and detail-oriented mindset
• Ability to lead and influence cross-functional teams
• Commitment to data integrity, compliance, and continuous improvement

Responsibilities

• Coordinate the sites aseptic process simulation program, working with Validation, Production and Quality Assurance to ensure it remains compliant, efficient, and aligned with regulatory expectations for 503B outsourcing facilities.
• Develop and approve media fill protocols that accurately model production operations, including interventions, personnel activities, and equipment configurations for each aseptic line.
• Oversee the planning and real-time execution of approximately 2-4 media fills per month, ensuring adherence to validated procedures, aseptic technique, and contamination control principles.
• Coordinate cross-functional support from manufacturing, quality control, and facilities.
• Ensure timely documentation, investigation, and closure of any protocol deviations, failures, or environmental anomalies identified during media fill events.
• Support the Aseptic Training team with analyzing performance trends to identify opportunities for improving aseptic practices, reducing risk, and optimizing fill efficiency.
• Work with the Aseptic Training team to ensure all involved in executing the APS are appropriately trained and qualified in aseptic technique, gowning, and simulation protocols.

Skills

Leadership

Project management

Communication

Problem-solving

Regulatory awareness

Cross-functional collaboration

Detail-oriented

Aseptic technique

Education

Bachelor's degree in Microbiology or Life Sciences

Tools

Electronic quality systems

Job description

Who We Are

Since 1990, weve grown into a global leader in personalized medicine. Today, our +5,000 energetic employees are based in +80 locations in Europe, North America, South America, Africa and Asia-Pacificand are working together to support over 200,000 customers worldwide. From compounding and natural products to software, equipment, and genomics we deliver smart, ready-to-use solutions that make healthcare better. We’re passionate, science-driven, and always looking for new ways to improve lives. ??

About the Job

The Specialist for the Aseptic Process Simulation Program organizes all aspects of aseptic process simulation (APS) activities at the 503B outsourcing facility. This individual coordinates the departments responsible for the design, execution, and implementation of media-fill protocols that qualify aseptic operations across multiple sterile areas and production lines.

The Aseptic Process Specialist works with the Validation department manager to ensure that all APS events are scientifically sound, compliant with FDA 503B guidance, cGMP Guidance for Sterile Manufacturing, and other relevant rules and guidelines, and that they accurately simulate routine production practices. The coordinator will report to Manufacturing Quality (MQ) and work with the MQ Aseptic Training team to improve aseptic processes.

Key Responsibilities

• Coordinate the sites aseptic process simulation program, working with Validation, Production and Quality Assurance to ensure it remains compliant, efficient, and aligned with regulatory expectations for 503B outsourcing facilities.
• Develop and approve media fill protocols that accurately model production operations, including interventions, personnel activities, and equipment configurations for each aseptic line.
• Oversee the planning and real-time execution of approximately 2-4 media fills per month, ensuring adherence to validated procedures, aseptic technique, and contamination control principles.
• Coordinate cross-functional support from manufacturing, quality control, and facilities.
• Ensure timely documentation, investigation, and closure of any protocol deviations, failures, or environmental anomalies identified during media fill events.
• Support the Aseptic Training team with analyzing performance trends to identify opportunities for improving aseptic practices, reducing risk, and optimizing fill efficiency.
• Work with the Aseptic Training team to ensure all involved in executing the APS are appropriately trained and qualified in aseptic technique, gowning, and simulation protocols.

Basic Qualifications

• Bachelors degree in Microbiology, Life Sciences, Engineering, or related discipline (advanced degree preferred).
• Minimum 5 years in sterile pharmaceutical manufacturing or 503B compounding.
• UnderstandingofFDA 503B guidance, cGMP (21 CFR Parts 210/211), and Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing current Good Manufacturing Practice.
• Leadership and project management capabilities.
• Communication, problem-solving, and decision-making skills.
• Proficiencyin electronic quality systems, deviation management, and protocol/repor authorship.
• Quality-driven and detail-oriented mindset
• Ability to lead and influence cross-functional teams
• Strong accountability and regulatory awareness
• Commitment to data integrity, compliance, and continuous improvement